Recycled Resin Compositions And Disposable Medical Devices Made Therefrom

ABSTRACT

Compositions including recycled resin components and medical devices and components made form such compositions are disclosed. The compositions and medical devices are characterized as biocompatible and sterilization stable. In one or more embodiments, the compositions include a recycled resin component and may include one or more of an anti-oxidant component, slip additive component, anti-static component, impact modifier component, colorant component, acid scavenger component, X-ray fluorescence agent component, radio opaque filler component, surface modifier component, melt stabilizer component, clarifier component, processing aid component and reinforcing agent component. Methods of forming medical articles and components are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/685,930 filed Apr. 14, 2015, which is a continuation of U.S. patentapplication Ser. No. 12/859,972, filed on Aug. 20, 2010, the disclosuresof which are incorporated herein by reference in their entirety.

TECHNICAL FIELD

The present invention relates to recycled resin compositions, medicaldevices formed from recycled resin compositions and methods formanufacturing medical devices from recycled resin compositions.

BACKGROUND

Plastics form a significant component of majority of disposable medicaldevices, non-disposable medical devices, medical device packaging aswell as other non-medical device applications including automotive andcommodity applications. These thermoplastics include polymers such aspolypropylene, polyethylene, polystyrene, polyethyleneterephthalate andpolycarbonate among others. Increasing use of plastics over the pastdecades has resulted in increased impact on landfill capacity and thedepletion of fossil fuel-based resources. The increasing use of plasticsor plastic material has also resulted in increasing level ofenvironmental pollution and associated carbon footprint.

In light of above, there has been an increased interest in theutilization of recycled thermoplastic polymeric materials, which may beobtained from a variety of sources. The increased interest in utilizingrecycled thermoplastic polymeric materials is driven by a number offactors, including increased customer awareness and concern forprotection of the environment, environmentally preferred purchasingpolicies developed by customers, recognition of benefits ofenvironmental stewardship in marketing by brand owners, development ofnew regulations and environmental policies intended to reduce the carbonfootprint, and a desire to reduce the increasing costs of storage and/orlandfill space coupled with more stringent regulations for disposal andincineration. The increased interest in utilizing recycled thermoplasticpolymeric materials is also driven by the improved capabilities ofrecyclers to consistently produce high quality recycled resins. Thesefactors have already resulted in extensive use of recycled plastics inautomotive and food packaging applications. For example, Ford MotorCompany has developed ways to increase the use of recycled materials inits vehicle manufacturing. Two exemplary outcomes of this developmentinclude Visteon Automotive Systems' recycling of thermoplastic scrapfrom automobile bumpers and E. I. du Pont de Nemours and Companyrecycling of scrap into automobile air cleaners. Recycled PET orpolyethylene terephthalate is extensively used in food and packagingapplications including beverage bottles.

In order to enhance the environmental stewardship of medical devices andability of healthcare agencies to satisfy environmental targets, forexample, the LEED system while reducing the impact on landfills, withoutsacrificing safety, there is a growing emphasis on manufacturing medicaldevices made from recycled plastics. Previous attempts to use recycledresins in manufacturing of medical devices or their components haveencountered obstacles such as lack of biocompatibility, lot-to-lotvariability in properties, and undesirable changes to the appearanceduring the sterilization process. Furthermore, when recycled resincompositions are used to form fluid path contact medical devices, thereis a concern that the recycled resin compositions will interfere withthe material being transmitted, carried or delivered through the medicaldevice.

Accordingly, there is a need in the industry for thermoplasticcompositions comprised of recycled resin compositions that arebiocompatible, sterilization-stable and are useful for medical deviceapplications. Such recycled resin compositions are not limited tomedical device applications and would apply to any industry that mayutilize such compositions that are sterilization-stable.

SUMMARY

A first aspect of the present invention pertains to a medical device. Inone or more embodiments, the medical device is formed from asterilization-stable recycled resin composition. In a more specificembodiment, the medical device is capable of withstanding sterilizationthat includes exposure to gamma rays in the range from about 5 kGys toabout 75 kGys. The medical device may be capable of withstandingsterilization that includes exposure to an electron beam in the rangefrom about 40 kGys to about 100kGys or exposure to X-ray radiation,exposure to ethylene oxide gas, autoclaving, plasma sterilization andother types of sterilization. At least a portion of the medical deviceof one or more embodiments may include a fluid-path contact medicaldevice or medical device that is in contact with fluid.

In one or more embodiments, the recycled resin composition isbiocompatible, as defined above. The composition may include recycledresin that may be present in an amount in the range from about 0.1% toabout 100% by weight. The recycled resin may include one ofpost-industrial recycled resin, post-consumer recycled resin andcombinations thereof. In one or more embodiments, the recycled resincomposition may include one or more of a virgin resin component and/or abiobased resin component.

The recycled resin composition may also include one or more of anantioxidant component, slip additive component, anti-static component,impact modifier component, colorant component, acid scavenger component,x-ray fluorescence agent component, radio opaque filler component,surface modifier component, processing aid component, melt stabilizer,clarifiers and reinforcing agent component. The anti-oxidant componentmay include one or more of hindered phenols and hindered amines and mayoptionally be present in an amount in up to about 10% by weight of therecycled resin composition. The impact modifier component utilized inone or more embodiments may include one or more of ethylene-butenecopolymer and ethylene octane copolymer. The acid scavenger componentmay include one or more of calcium stearate, dihydro talcite, calciumlactate and monopotassium citrate. The radio opaque filler may includeone or more of barium sulfate, bismuth subcarbonate, bismuth trioxide,bismuth oxychloride and tungsten, while the colorant component mayinclude organic dyes, inorganic pigments, carbon black, channel blackand titanium dioxide. The processing aid component utilized in one ormore embodiments may include one or more of a fatty acid ester, fattyacid amide, wax and oxidized polyethylene. The reinforcing agentcomponent may include one or more of glass fibers, cinderash, naturalfibers and minerals, carbon fibers, ceramic fillers, which may beprovided as nanoparticles or nanofibers.

The medical device of one or more embodiments may include a plunger rod,needle shield, handle, safety shield. In embodiments in which themedical device is a plunger rod, it exhibits functional performance thatis acceptable to users including clinicians. In other words, the plungerrod may exhibit functional performance that is the same or greater thanthe functional performance exhibited by plunger rods formed from anon-recycled resin composition. The medical devices described herein maybe formed by molding or extruding.

A second aspect of the present invention pertains to a composition formolding a medical device. The composition includes a recycled resinsourced from a traceable source and may optionally include one or moreof an antioxidant component, slip additive component, anti-staticcomponent, impact modifier component, colorant component, acid scavengercomponent, x-ray fluorescence agent component, radio opaque fillercomponent, surface modifier component, processing aid component, meltstabilizer component, clarifier component, nucleating agents andreinforcing agent component, as otherwise described above. In one ormore embodiments, the composition is capable of withstanding exposure togamma rays in the range from about 5 kGys to about 75 kGys. In anothervariant, the composition is capable of withstanding exposure to electronbeams in the range from about 30 kGys to about 100 kGys. The compositionmay also optionally be capable of withstanding exposure to one of X-rayradiation, ethylene oxide gas, autoclaving and plasma sterilization.

The composition may be utilized to form the medical devices describedherein. The composition may include one or more of a virgin resincomponent and a biobased resin component.

A third aspect of the present invention pertains to a method of forminga medical device. In one or more embodiments, the method includesproviding a melt blend composition including a 50% to 99% recycled resincomponent, stabilizing the composition to withstand exposure to gammarays, electron beams, X-ray radiations, ethylene oxide gas, autoclave,plasma sterilization and solidifying the composition in a pre-selectedshape. In one or more embodiments, the method includes stabilizing thecomposition to withstand exposure to gamma rays in the range from about5 kGys to about 75 kGys.

In one or more embodiments, the step of providing a melt blendcomposition includes feeding a recycled resin component and one or moreof an antioxidant component, slip additive component, anti-staticcomponent, impact modifier component, colorant component, acid scavengercomponent, nucleating agents, clarifiers, x-ray fluorescence agentcomponent, radio opaque filler component, surface modifier component,processing aid component and reinforcing agent component into a meltcompounding extruder. The step of solidifying the composition mayinclude injection molding the composition, extruding the composition,blow molding the composition and rotational molding the composition.

In one or more embodiments, the composition may be solidified in apre-selected shape that includes one of a plunger rod, a syringe barrel,a catheter, a blood collection device, a surgical blade handle, a needleshield, safety shield, catheter wings, catheter flow control plugs and aneedle hub, sharps containers, body fluid collection devices, tubing,adapters and drainage tubes.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded view of a syringe assembly of one or moreembodiments of the present invention; and

FIG. 2 illustrates a perspective view of a scalpel and scalpel shieldaccording to one or more embodiments.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

As used herein, the term “medical device” shall include all devices andcomponents used in conjunction with other components in devices that areused in all medical and/or laboratory purposes, excluding wastecollection containers such as sharps collection containers. Medicaldevices include syringe assemblies, including syringe barrels, plungerrods, catheters, needle hubs and needle shields, safety shields,surgical blades, surgical handles, sharps containers, body fluidcollection devices, tubing, adapters, shunts, drainage tubes,guidewires, stents, petri dishes, culture bottles, centrifuge tubes,blood collection devices and the like. As indicated, as used herein“medical devices” excludes waste collection containers such as sharpscollection containers.

As used herein, the term “biocompatible” shall mean any substance thatis not toxic to the body or biological environment or does not producean undesirable biological response during the period of exposure to thehuman body. A composition is biocompatible if the composition, and anydegradation products of the composition, are non-toxic to the recipientor biological environment and also present no significant deleteriouseffects on the biological environment. A medical device is biocompatibleif the medical device, and any degradation products of the medicaldevice, are non-toxic to the recipient or biological environment andalso present no significant deleterious effects on the biologicalenvironment.

In addition, as used herein, the term “sterilization-stable” shall meanthe ability of a medical device or component to withstand sterilizationwithout significant loss of functional performance and mechanicalproperties. Sterilization includes exposure to radiation, for example,gamma rays and/or X-rays, during the sterilization process. Medicaldevices or components thereof that are capable of withstanding radiationsterilization without significant loss of functional performance may bereferred to as “radiation stable.” An example of a sterilization processmay include exposure of a medical device to high energy photons that areemitted from an isotope source, for example Cobalt 60, which producesionization or electron disruptions throughout the medical device.Sterilization may also include ethylene oxide sterilization, electronbean sterilization, autoclave (steam sterilization), plasmasterilization, dry heat sterilization, and X-ray beam sterilization.

As used herein, “fluid path contact medical devices” are medical deviceswherein at least a portion of the medical device comes into contact orinteracts with fluids and/or solids, for example, medications, solutionsof medications, drug containing solutions, flush solutions, body fluids,human tissue, or any material that is intended to be isolated to preventcontamination. As used herein, reference to a medical device “formedfrom a sterilization-stable recycled resin composition” means that thedevice is manufactured, for example, shaped from a resin obtained fromrecycled resin. Accordingly, a medical device “formed from asterilization-stable recycled resin composition” does not include amedical device that is used, and then reprocessed by cleaning orsterilization of a part of or the entire device by radiation or in anautoclave. Such reuse of medical device is often referred to as“reprocessing”, and reprocessed medical devices are not within the scopeof a device formed from a sterilization-stable recycled resincomposition because such reprocessing does not include shaping or othermanufacturing process to form a device from a resin composition

A first aspect of the present invention pertains to compositions for usein molding a medical device that includes a recycled resin from atraceable source. A second aspect of the present invention pertains to amedical device that is formed from a recycled resin composition. A thirdaspect of the present invention pertains to a method of forming amedical device.

The recycled resin compositions of one or more embodiments of the firstaspect may include a post-industrial recycled resin. The amount ofpost-industrial recycled resin may be present in the recycled resincomposition in the range from about 0.1% to about 100% by weight of therecycled resin composition. In one or more embodiments, the recycledresin composition includes post-industrial recycled resin in an amountin the range from about 50% to about 99% by weight. In one or morespecific embodiments, the recycled resin composition may includepost-industrial recycled resin in an amount in the range from about 20%to about 80% by weight. In a more specific embodiment, the lower limitof the amount of post-industrial recycled resin may include 25%, 30%,35%, 40%, 45% and 50% by weight of the recycled resin composition andall ranges and sub-ranges therebetween. The upper limit of the amount ofpost-industrial recycled resin may include 75%, 70%, 65%, 60%, 55% and50% by weight of the recycled resin composition and all ranges andsub-ranges therebetween.

The recycled resin compositions of one or more embodiments of the firstaspect may include a post-consumer recycled resin. The resin may beprovided in any suitable form, such as in the form of flakes, chips,pellets and the like. In one variant, the recycled resin compositionsmay include post-consumer recycled resin and post-industrial recycledresin. The amount of post-consumer recycled resin may be present in therecycled resin composition in the range from about 0.1% to about 100% byweight of the recycled resin composition. In one or more embodiments,the recycled resin composition includes post-consumer recycled resin inan amount in the range from about 50% to about 99% by weight. In one ormore specific embodiments, the recycled resin composition may includepost-consumer recycled resin in an amount in the range from about 20% toabout 80% by weight. In a more specific embodiment, the lower limit ofthe amount of post-consumer recycled resin may include 25%, 30%, 35%,40%, 45% and 50% by weight of the recycled resin composition and allranges and sub-ranges therebetween. The upper limit of the amount ofpost-consumer recycled resin may include 75%, 70%, 65%, 60%, 55% and 50%by weight of the recycled resin composition and all ranges andsub-ranges therebetween.

Examples of suitable post-industrial recycled resins and post-consumerrecycled resins include polypropylene, polycarbonates, nylons,polyethyleneterphthalates, polyesters, polyethylenes, polystyrenes, polylactic acid, polyhyroxyalkanoates, bioderived polyolefins includingpolyethylene and polypropylene and other resins known in the art thatare recyclable and combinations thereof. The recycled resins may havebeen recovered or otherwise diverted from the solid waste stream, eitherduring the manufacturing process (pre-consumer), or after consumer use(post-consumer).

In one or more embodiments, the recycled resin composition may alsoinclude one or more of the optional additives. These optional additivesare selected from the group consisting of anti-oxidants, slip additives,anti-static agents, impact modifiers, a colorants, acid scavengers,X-ray fluorescence agents, radio opaque fillers, surface modifiers,processing aids including melt stabilizers, nucleating agents includingclarifiers, flame retardants, inorganic fillers other than finelypowdered talc, organic fillers and other polymers and reinforcingagents.

In one or more embodiments, the recycled resin composition includes ananti-oxidant component. The anti-oxidant component may include chemicalcompounds that inhibit oxidation via chain terminating reactions. In oneor more embodiments, the anti-oxidant component may be present in therecycled resin composition in an amount up to about 10% by weight of therecycled resin composition. In one or more specific embodiments, therecycled resin composition may include an anti-oxidant component in anamount of up to about 5% by weight or, more specifically, an amount ofup to about 1% by weight of the recycled resin composition. In one ormore specific embodiments, the anti-oxidant component may be present inan amount in the range from about 1% by weight to about 5% by weight ofthe recycled resin composition. In an even more specific embodiment, theanti-oxidant component may be present in an amount in the range fromabout 0.1% to about 1% by weight of the recycled resin composition. Theupper limit of the amount of the anti-oxidant component may include0.9%, 0.8%, 0.7%, 0.6% and 0.5% and all ranges and sub-rangestherebetween.

In one or more embodiments, the anti-oxidant component is present in anamount sufficient to inhibit oxidation reactions during sterilizationand over the shelf life and/or use-phase of the product.

Non-exclusive examples of suitable anti-oxidant components includehindered phenols, hindered amines, phosphites and/or combinationsthereof. Hindered phenols include chemical compounds that act ashydrogen donors and react with peroxy radicals to form hydroperoxidesand prevent the abstraction of hydrogen from the polymer backbone.Suitable hindered phenols include buylated hydroxytoluene. Othersuitable hindered phenols are available under the trademark Irganox®1076, Irganox® 1010, and Jrganox®E 201, from Ciba, Inc., now part ofBASF Corporation of Ludwigshafen, Germany. Other examples of hinderedphenols include BNX® 1010 and BNX® 1076TF from Mayzo Inc. or Norcross,Ga., U.S.A. Suitable hindered phenols are also available under thetrademark Ethanox®330 and Ethanox® 376 from Albemarle Corporation ofBaton Rouge, La., U.S.A.

Hindered amines include chemical compounds containing an aminefunctional group surrounded by a steric environment. They are extremelyefficient stabilizers against light-induced degradation of mostpolymers. Examples of suitable hindered amines includebis(1,2,2,6,6-pentamethyl-4-piperidinyl)-2-n-butyl-2-(3,5-di-tert-butyl-4-hydroxybenzyl)malonate;bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate,bis(1,2,3,6,6-pentamethyl-4-piperidinyl)sebacate andbis(1,2,2,6,6-pentamethyl-4-piperidinyl)sebacate. These are commonlyreferred to as Tinuvin 144, Tinuvin 770, Tinuvin 292 and Tinuvin 765respectively and are available from the Ciba-Geigy Corporation, now partof BASF Corporation of Ludwigshafen, Germany. Other examples of suitablehindered amines are available under the tradenames Uvasorb HA-88 from 3VSigma SpA of Bergamo, Italy, and Chimassorb 944 and Chimassorb 994 fromBASF Corporation of Ludwigshafen, Germany.

In specific embodiments, the recycled resin composition includes a slipadditive component. The slip additive component may include chemicalcompounds reduce the surface coefficient of friction of polymers and areused to enhance either processing or end applications. The slip additivecomponent may be present in the recycled resin composition in an amountin the range from about 0.001% to about 5% by weight of the recycledresin composition and all ranges and sub-ranges therebetween. In one ormore specific embodiments, the slip additive component is present in anamount in the range from about 1% to about 2% by weight of the recycledresin composition. The upper limit of the amount of the slip additivecomponent may include 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.The lower limit of the amount of the slip additive component may include0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, and 0.9%by weight of therecycled resin composition and all ranges and sub-ranges therebetween.Examples of suitable slip additive components include oleamides,erucamide, Oleyl palmitamide, Stearyl erucamide, Ethylene-bis-oleamide,waxes and combinations thereof.

The recycled resin composition optionally includes an anti-staticcomponent. The anti-static component may include chemical compounds thatprevent or reduce the accumulation of static electricity. Theanti-static component acts to permit the body or surface of the materialto be static dissipative, preventing the formation of static charges andhindering the fixation of dust. The anti-static component may beincorporated in the material before molding, or applied to the surfaceafter molding and function either by being inherently static dissipativeor by absorbing moisture from the air. The anti-static component may bepresent in the recycled resin composition in an amount in the range fromabout 0.01% to about 5% by weight of the recycled resin composition andall ranges and sub-ranges therebetween. In one or more specificembodiments, the anti-static component is present in an amount in therange form about 0.1% to about 3.0% by weight of the recycled resincomposition and all ranges and sub-ranges therebetween. The upper limitof the amount of the anti-static component may include 4.5%, 4.0%, 3.5%,3.0% and 2.5% by weight of the recycled resin composition and all rangesand sub-ranges therebetween. The lower limit of the amount of theanti-static component may include 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%,0.7%, 0.8%, 0.9% and 1.0% by weight of the recycled resin compositionand all ranges and sub-ranges therebetween. Examples of anti-staticagent components are long-chain aliphatic amines and amides, phosphateesters, quaternary ammonium salts, polyethylene glycols, polyethyleneglycol esters, ethoxylated long-chained aliphatic amines andcombinations thereof. Other examples of suitable anti-static agents areavailable under the trade name Pelestat 230 and Pelestat 300 from ToyotaTsusho Corporation of Nagoya, Japan, Atmer™ 163 from Uniqema, now partof Croda International Plc of Yorkshire, England, U.K, Entira™ MK 400from E.I DuPont de Nemours and Company of Wilmington, Del., U.S.A andNourymix® AP 375 and 775 from Akzo Nobel N.V. of Amsterdam, theNetherlands.

The recycled resin composition optionally includes an impact modifiercomponent. The impact modifier component may include chemical compoundsfor improving the impact resistance of finished articles or devices. Theimpact modifier component may be present in the recycled resincomposition in an amount in the range from about 0.1% to about 30% byweight of the recycled resin composition. In one or more specificembodiments, the impact modifier component is present in an amount inthe range form about 0.5% to about 5% by weight of the recycled resincomposition and all ranges and sub-ranges therebetween. The upper limitof the amount of impact modifier component may include 4.5%, 4.0%, 3.5%,3.0%, 2.5% and 2.0% by weight of the recycled resin composition and allranges and sub-ranges therebetween. The lower limit of the amount ofimpact modifier component may include 0.75%, 1.0%, 1.25%, 1.5%, 1.75%and 2.0% by weight of the recycled resin composition and all ranges andsub-ranges therebetween. Examples of suitable impact modifier componentsinclude ethylene-butene copolymers, ethylene octene copolymers,ethylene-propylene copolymers, methacrylate butadiene-styrene core shellimpact modifiers and combinations thereof. Examples of suitable impactmodifier agents are available under the trade name Elvaloy® EAC3427 fromE.I DuPont de Nemours and Company of Wilmington, Delaware, U.S.A.,Engage™ and Versify™ from the Dow Chemical Company of Midland, Mich.,U.S.A. and Clearstrength™ from Arkema Inc. of Philadelphia, Pa., U.S.A.

When present, the impact modifier component can be present in an amountsufficient to meet the impact requirements of the fabricated medicalarticle.

The recycled resin composition optionally includes an acid scavengercomponent. The acid scavenger component may include chemical compoundsfor preventing discoloration or premature aging of the polymer as wellas the fabricated medical article from the acidic impurities during thecourse of manufacturing, processing, sterilization, shelf life or usephase. For example, such chemical compounds may neutralize halogenanions found in resin compositions that may be formed due to theinfluence of heat and shear during processing. The acid scavengercomponent scavenges these halogenic acids to prevent polymer degradationor corrosion. The acid scavenger component may be present in therecycled resin composition in an amount in the range from about 0.01% toabout 1% by weight of the recycled resin composition. In one or morespecific embodiments, the acid scavenger component is present in anamount in the range form about 0.1% to about 0.5% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.The upper limit of the amount of acid scavenger component may include0.6%, 0.7%, 0.8%, and 0.9% by weight of the recycled resin compositionand all ranges and sub-ranges therebetween. The lower limit of theamount of acid scavenger component may include 0.01%, 0.02%, 0.03%,0.04%. 0.05%, 0.06%. 0.07%, 0.08% and 0.09% by weight of the recycledresin composition and all ranges and sub-ranges therebetween. Examplesof suitable acid scavenger components include metal salts of long chaincarboxylic acids like calcium, zinc or sodium stearates, lactates,natural or synthetic silicates like hydrotalcites, metal oxides (e.g.magnesium oxide, calcium oxide, zinc oxide), metal carbonates (e.g.calcium carbonate) or metal hydroxides (see e.g. A Holzner, K Chmil inH. Zweifel, Plastic Additives Handbook, 5^(th) Ed., Hanser Publisher,Munich 2001, Chapter 4 Acid Scavengers). Suitable examples of acidscavengers include calcium stearate, dihydro talcite, calcium lactate,mono potassium citrate and combinations thereof.

When present, the acid scavenger component can be present in therecycled resin composition in an amount sufficient to inhibitdiscoloration and prevent degradation caused by acidic impurities duringmanufacturing, processing, storage, shelf life or use phase of polymerand medical article fabricated therefrom.

Another optional component of the recycled resin composition is a radioopaque filler component. The radio opaque filler component may includechemical compounds for that cause medical devices formed from the resincomposition to be visible under fluoroscopy or x-ray imaging. The radioopaque filler component may be present in the recycled resin compositionin an amount in the range from about 10% to about 48% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.In one or more specific embodiments, the radio opaque filler componentis present in an amount in the range from about 22% to about 25% byweight of the recycled resin composition and all ranges and sub-rangestherebetween. The upper limit of the amount of the radio opaque fillercomponent may include 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%and 46% by weight of the recycled resin composition and all ranges andsubranges therebetween. The lower limit of the amount of the radioopaque filler component may include 11%, 12%, 13%, 14%, 15%, 16%, 17%,18%, 19% and 20% by weight of the recycled resin composition and allranges and subranges therebetween. Higher percentages of radio opaquefiller component may also be used. For example, the amount of the radioopaque filler component may be more than about 50% by weight of therecycled resin composition. Examples of suitable radio opaque fillercomponents include barium sulfate, bismuth subcarbonate, bismuthtrioxide, bismuth oxychloride, tungsten and combinations thereof.

The radio opaque filler component can be present in an amount sufficientto enable visibility of the medical devices using x-ray and otherradiology imaging techniques.

The recycled resin composition further optionally includes a surfacemodifier component. The surface modifier component may include chemicalcompounds or materials which tailor the surface of the fabricatedcomponent(s) to meet or enhance adhesion, lubricity and/or physicalproperties. The surface modifier component may be present in therecycled resin composition in an amount in the range from about 0.1% toabout 10% by weight of the recycled resin composition. In one or morespecific embodiments, the surface modifier component is present in anamount in the range form about 0.5% to about 5%, more preferably between0.2 to 1% by weight of the recycled resin composition and all ranges andsub-ranges therebetween. The upper limit of the amount of the surfacemodifier component may include 1.5%, 2.0%, 3.0%, 3.5%, 4.0% and 4.5% andall ranges and sub-ranges therebetween. The lower limit of the amount ofthe surface modifier component may include 0.3%, 0.35%, 0.4% and 0.45%by weight of the recycled resin composition and all ranges andsub-ranges therebetween. In one or more embodiments, higher percentagesof surface modifiers may also be used. Examples of suitable surfacemodifier components include diatomaceous earth, talc, calcium carbonate,organosilanes, titanates, maleated polyolefins, powdered PTFE andcombinations thereof.

The surface modifier can be present in the recycled resin composition inan amount sufficient to impart desirable surface property to the surfaceof the fabricated medical device.

In one or more embodiments, the recycled resin composition includes acolorant component. The colorant component may be present in therecycled resin composition in an amount in the range from about 0.01% toabout 5% by weight of the recycled resin composition. In one or morespecific embodiments, the colorant component(s) are present in an amountin the range form about 0.5% to about 3% by weight of the recycled resincomposition and all ranges and sub-ranges therebetween. The upper limitof the amount of colorant component may include 3.25%, 3.5%, 3.75%,4.0%, 4.25%, 4.5% and 4.75% by weight of the recycled resin compositionand all ranges and sub-ranges therebetween. The lower limit of theamount of the colorant component may include 0.1%, 0.15%, 0.2%, 0.25%,0.3%, 0.35%, 0.4% and 0.45% by weight of the recycled resin compositionand all ranges and sub-ranges therebetween. Examples of suitablecolorant components include organic dyes, inorganic pigments, carbonblack, channel black, titanium dioxide and combinations thereof. Organicdyes may include Phthalocyanine blue and Phthalocyanine green, and FD&Ccolorants. Exemplary inorganic pigments include ultramarines and ironoxides.

Another optional component of the recycled resin composition includes aprocessing aid component. The processing aid component may includechemical compounds which improve the processability of high molecularweight polymers, reduces the cycle time and help improve quality offinished products. The processing aid component may be present in therecycled resin composition in an amount in the range from about 0.05% toabout 5% by weight of the recycled resin composition and all ranges andsub-ranges therebetween. In one or more specific embodiments, theprocessing aid component is present in an amount in the range form about0.1 to about 3% by weight of the recycled resin composition and allranges and sub-ranges therebetween. The upper limit of the amount ofcolorant component may include 3.25%, 3.5%, 3.75%, 4.0%, 4.25%, 4.5% and4.75% by weight of the recycled resin composition and all ranges andsub-ranges therebetween. The lower limit of the amount of the colorantcomponent may include 0.06%, 0.07%, 0.08% and 0.09% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.Higher percentages of processing aid may also be used. Examples ofsuitable processing aid components include fatty acid esters, fatty acidamines, waxes, oxidized polyethylenes, colloidal fumed silica particlesand combinations thereof. Colloidal fumed silica particles are availableunder the tradename Nan-O-Sil ASD from Energy Strategy Associates, Inc.of Old Chatham, N.Y., USA. Glycerol monostearates and bisstearaamidesare suitable fatty acid esters and fatty acid amides.

The recycled resin composition may optionally include a nucleatingagents and/or clarifier component. Nucleating agents may includechemical compounds that enhance resin performance properties such asstiffness and heat resistance. A clarifier may also be added to enhancethe aesthetic appeal of a formed product by making it more transparent.In one or more embodiments, the nucleating and/or clarifier component ispresent in an amount in the range from about 0.005% to about 3% byweight of the recycled resin composition. Higher percentages ofnucleating and/or clarifying agents may be used but generally provide noperceived advantages. In one or more specific embodiments, the clarifiercomponent is present in an amount in the range from about 0.05 to about0.5% by weight of the recycled resin composition and all ranges andsub-ranges therebetween. The upper limit of the amount of the clarifiercomponent may include 1.0%, 1.5%, 2.0% and 2.5% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.The lower limit of the amount of the clarifier component may include0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04% and 0.045% by weightof the recycled resin composition and all ranges and sub-rangestherebetween. Examples of clarifier components include dibenzylidenesorbitol as described in U.S. Pat. No. 4,016,118, which is incorporatedherein by reference, substituted dibenzylidene sorbitol as described inU.S. Pat. No. 4,371,645, which is incorporated herein by reference, anddibenzylidene sorbitol thioether derivatives as described in U.S Pat.No. 4,994,552, which is incorporated herein by reference.

When present, the clarifiers can be present in an amount sufficient suchthat the size of the size of the crystals in the resulting resincomposition is smaller than the wavelength of visible light to preventlight scattering, which causes opacity.

The recycled resin composition optionally includes a reinforcing agentcomponent. The reinforcing agent component may be present in therecycled resin composition in an amount in the range from about 1% toabout 35% by weight of the recycled resin composition. In one or morespecific embodiments, the reinforcing agent component(s) are present inan amount in the range from about 5% to about 30% by weight of therecycled resin composition and all ranges and sub-ranges therebetween.The upper limit of the amount of the reinforcing agent component mayinclude 30.5%, 31%, 31.5%, 32%, 32.5%, 33%, 33.5%, 34% and 34.5% byweight of the recycled resin composition and all ranges and sub-rangestherebetween. The lower limit of the amount of the reinforcing agentcomponent may include 1.5%, 2%, 2.5%, 3%, 3.5%, 4% and 4.5% by weight ofthe recycled resin composition and all ranges and sub-rangestherebetween. Examples of suitable reinforcing agent components includeglass fibers, cinderash, natural fibers and minerals, carbon fibers,ceramic fibers, and combinations thereof. Examples of natural fibersinclude flax fibers and kenaf fibers and fillers. The reinforcing agentcomponent may be present in the recycled resin composition in the formof nanofibers and/or nanoparticles.

The recycled resin composition according to one or more embodiments mayoptionally include a melt stabilizer component. The melt stabilizercomponent may include chemical compounds for adjusting the viscosity ofthe recycled resin composition during a melting process.

The recycled resin composition may also optionally incorporate anon-recycled resin component. Examples of a non-recycled resin componentinclude virgin resin components, biobased resin components andcombinations thereof. Virgin resin components are resin compositionsthat do not include a significant amount of recycled resin. In one ormore embodiments, virgin resin components are free of recycled resin.Virgin resin components may also include “fossil fuel-based polymers” or“petroleum based polymers,” which shall be used interchangeably, andinclude, without limitation, polymers formed from non-renewable sourcessuch as fossil fuel sources. Such polymers include polypropylene,polyethylene not derived from sugar or other renewable resources,polycarbonate.

The term “biobased” may be used interchangeably with the terms“bioformed” and “bioderived.” The biobased component includes polymersthat are derived, produced or synthesized in whole or in significantpart, from biological sources or renewable domestic agriculturalmaterials (including plant, animal, and marine materials) or forestrymaterials. The biobased component includes polymers in which carbon isderived from a renewable resource via biological processes such asmicrobiological fermentation. The biobased component may also includepolymers with cellulose-based materials of different grades. Thebiobased component may also include polymers are that substantially freeof materials derived from fossil fuel or non-renewable resources asdetermined by ASTM D6866-08.

The biobased component used herein may include polymers which arederived from biological sources, such as plants, and includepolysaccharide-derived polymers, such as starch- or carbohydrate-derivedpolymers, and sugar-derived polymers. The starch used to form bioformedpolymers may be derived from corn, potatoes, wheat, cassava, rice andother plants. An example of a composition containing bioformed polymerderived from starch is available from Cereplast Inc., Hawthorne, Calif.,U.S.A., under the trademarks and trade names Cereplast Hybrid Resins ,Bio-polyolefins, or Biopropylene 50™. The sugar used to form suchbioformed polymers may be derived from sugar cane. Such sugar-derivedpolymers include polyethylene, which may be produced from ethanolderived from sugar cane, which is then used to produce ethylene andpolymers are available from Novamount S.P.A., Novara, Italy under thetrademark MATER-BI®. Other examples of bioformed polymers are describedin U.S. Pat. No. 7,393,590, U.S. Patent Application Publication Nos.2008/0113887 and 2008/0153940, PCT Application Publication Nos.WO07/099427 and WO07/063361 and European Patent No. 1725614, each ofwhich is incorporated herein in their entirety by reference. A specificexample of a bioformed polymer includes “poly(lactic acid)” or “PLA,”which may include a synthetic polymer produced from cane sugar orcornstarch. PLA is available from NatureWorks LLC, Minnetonka, Minn.,U.S.A., under the trade name Ingeo™. Embodiments utilizing PLA may alsoinclude an ethylene copolymer. Ethylene copolymers are available from E.I. du Pont de Nemours and Company, Wilmington, Del., U.S.A., under thetrademark BIOMAX®.

Biobased component includes polymers may also be produced from microbes.Microorganisms produce substances, including polymers, by growth onfeedstock, including sugar feedstock. The production of these polymersmay also involve bacterial fermentation of sugar or lipids. The biobasedcomponent may be further treated or synthesized from natural products.Examples of such produced and/or synthesized biobased polymers includepolyhydroxyalkanoates The term “polyhydroxyalkanoate” or “PHA” includeslinear polyesters produced in nature by bacterial fermentation of sugaror lipids. Examples of PHAs include poly(hydroxybutyrate) andpoly(hydroxyvalerate) or “PHBV.” PHAs may exhibit properties such aselasticity. PHAs are available from Metabolix, Inc., Cambridge, Mass.,U.S.A., under the trademark MIREL®.

Recycled resin compositions according to one or more embodiments, arebiocompatible, as defined herein. In one or more embodiments, therecycled resin composition is capable of withstanding exposure to gammarays, electron beams, X-rays, ethylene oxide gas, dry heat, peroxide gasplasma, peracetic acid, steam autoclave and other means ofsterilization. In one or more embodiments, the recycled resincomposition is radiation stable and capable of withstanding exposure togamma rays in the range from about 5 kGys to about 75 kGys, or morespecifically, in the range from about 25 kGys to about 50 kGys. In oneor more embodiments, the recycled resin composition is capable ofwithstanding exposure to electron beams in the range from about 30 kGysto about 80 kGys, or, more specifically, in the range from about 40 kGysto about 70 kGys.

The recycled resin composition according to one or more embodiments hasa melt flow rate in the range from about 3 dg/minute to about 80dg/minute. In one or more specific embodiments, the recycled resincomposition has a melt flow rate in the range from about 8 dg/minute toabout 40 dg/minute. In even more specific embodiments, the recycledresin composition has a melt flow rate in the range from about 11dg/minute to about 30 dg/minute. As used herein, the term “melt flowrate” refers to the ease of flow of the melt of the recycled resincompositions described herein.

The recycled resin compositions described herein may have a flexuralmodulus in the range from about 70 kpsi to 350 kpsi and all ranges andsubranges therebetween as measured according to ASTM D790 test method.In one or more specific embodiments, the recycled resin compositionshave a flexural modulus in the range from about 100 kpsi to about 300kpsi. In even more specific embodiments, the recycled resin compositionsexhibits a flexural modulus in the range from about 130 kpsi to about270 kpsi.

The recycled resin composition may be characterized by having notchedizod impact strength in the range from about 0.1 ft-lb/in. to about 4.0ft-lb/in and all ranges and subranges as measured according to ASTM D256test method. In one or more embodiments, the recycled resin compositionmay have notched izod impact strength in the range from about 0.2ft-lb/in. to about 1.5 ft-lb/in. In one or more specific embodiments,the recycled resin composition may have a notched izod impact strengthin the range from about 0.3 ft-lb/in. to about 1.0 ft-lb/in. As usedherein, the term “notched izod impact strength” refers to the ASTMstandard method of determining impact strength.

One or more embodiments of the recycled resin composition describedherein may be characterized by having a heat deflection temperature inthe range from about 60° C. to about 260° C. As used herein, the term“heat deflection temperature” includes a measure of a polymer'sresistance to distortion under a given load at elevated temperature. Theheat deflection temperature is also known as the ‘deflection temperatureunder load’ (DTUL), deflection temperature, or ‘heat distortiontemperature’ (HDT). The two common loads used to determine heatdeflection temperature are 0.46 MPa (66 psi) and 1.8 MPa (264 psi),although tests performed at higher loads such as 5.0 MPa (725 psi) or8.0 MPa (1160 psi) are occasionally encountered. The common ASTM test isASTM D 648 while the analogous ISO test is ISO 75. The test using a 1.8MPa load is performed under ISO 75 Method A while the test using a 0.46MPa load is performed under ISO 75 Method B. In one or more specificembodiments, the recycled resin composition may have a heat deflectiontemperature in the range from about 68° C. to about 140° C. In even morespecific embodiments, the recycled resin composition may have a heatdeflection temperature in the range from about 70° C. to about 95° C. Inone or more embodiments which utilize a post-industrial recycled resincomponent comprising polycarbonate, the recycled resin composition has aheat deflection temperature of about 140° C. at a load of 0.46 MPa and130° C. at a load of 1.8 MPa. In one or more embodiments which utilize apost-industrial recycled resin component comprising nylon and areinforcing agent component including glass fibers, the recycled resincomposition has a heat deflection temperature of about 220° C. at a loadof 0.46 MPa and 200° C. at a load of 1.8 MPa. In embodiments whichutilize a post-industrial recycled resin component comprising PET and areinforcing agent component including glass fibers, the recycled resincomposition has a heat deflection temperature of about 250° C. at a loadof 0.46 MPa and 230° C. at a load of 1.8 MPa.

Preparation of the recycled resin compositions of this invention can beaccomplished by any suitable blending or mixing means known in the art.The blending step should, at least minimally, disperse the componentsamongst each other. The components may be blended together in a one-stepprocess or a multi-step process. In the one-step process, all thecomponents are blended together at the same time. In the multiple-stepprocess, two or more components are blended together to form a firstmixture and then one or more of the remaining components are blendedwith the first mixture. If one or more components still remain, thesecomponents may be blended in subsequent mixing steps. In one or moreembodiments, all the components are blended in a single step.

In one or more alternative embodiments, the recycled polypropylenecomposition may be prepared by dry blending the individual componentsand subsequently melt mixing, either directly in the extruder used tomake the finished article, or premixing in a separate extruder. Dryblends of the composition may also be directly injection molded withoutpre-melt mixing.

The recycled resin compositions disclosed herein are utilized to mold,extrude or otherwise form a medical device. In one or more embodiments,the medical device is disposable. For example, the medical devices maybe formed from the recycled resin compositions described herein may beused in injection, infusion, blood collection, surgical applications andother applications known in the art. Specific examples of medicaldevices that may be formed form the recycled resin compositionsdescribed herein include syringes (including syringe barrels, needle hubparts, plunger rods, needle shields and the like), safety syringes,catheters, blood collection devices, surgical blades or scalpels andother such devices and components. In one or more alternativeembodiments, the medical device may be entirely or partially molded froma recycled resin composition. For example, the inside surface of asyringe barrel may be formed from a resin composition that is notrecycled while the outside surface of the syringe barrel or the fingerflanges of the syringe barrel are made from a recycled resincomposition. In one or more alternative embodiments, the scalpel handleor needle shield are formed from a recycled resin composition.

In one or more embodiments, the medical devices formed from the recycledresin compositions described herein may be characterized as non-fluidpath contact components or medical devices. As such, the medical devicesand components do not interact or come into contact with fluids and/orsolids, for example, medications, solutions of medications, drugcontaining solutions, flush solutions, body fluids, human tissue, or anymaterial that is intended to be isolated to prevent contamination.Examples of such devices include syringe plunger rods of a three-piecesyringe, needle shields, safety shields of injection devices and thefinger flanges of a syringe barrel, handle of peripheral IV catheter,catheter wings, catheter flow control plug etc. Medical devices andcomponents formed from recycled resin compositions may also becharacterized as fluid path contact medical devices. Such medicaldevices or medical device components may include syringe barrels, needlehubs, surgical blade handles, valve housings, syringe stopper, plungerrod of a two piece syringe.

Non-limiting examples of medical devices are illustrated in FIGS. 1 and2. FIG. 1 illustrates a syringe assembly 100 including a syringe barrel110 with an inside surface defining a chamber, a plunger rod 120disposed within the chamber, a needle hub 130 including a needle cannula140 for attachment to the syringe barrel. FIG. 1 also illustrates anoptional needle shield 150 to be attached to the needle hub 130 toprotect and cover the needle cannula 140. The plunger rod 120 mayinclude a separate stopper 125 attached to one end of the plunger rod120 for forming a fluid tight seal with the inside surface of thesyringe barrel, as shown in FIG. 1. In one or more alternativeembodiments, the plunger rod 120 may include a sealing portion (notshown) that functions as a stopper, and may be integrally molded withthe plunger rod 120 and thus formed form the same material as theplunger rod 120. The syringe barrel 110 shown in FIG. 1 also includes aluer fitting 112 at one end of the syringe barrel 110 and a fingerflange 114 at the opposite end of the syringe barrel 110.

In one variant, the syringe barrel may be entirely formed from therecycled resin compositions disclosed herein. Alternatively, the luerfitting 112 and/or the finger flanges 114 may be formed from therecycled resin compositions disclosed herein, while the syringe barrel110 is formed from known resin compositions that may include virginresin components and/or biobased resin components, and are free of anyrecycled resin. In one or more alternative configurations, the insidesurface of the syringe barrel 110 may be coated with known a resincomposition(s) that may include virgin resin components and/or biobasedresin components, and are free of any recycled resin, while theremainder of the syringe barrel 110 is formed form one or more of therecycled resin compositions described herein.

In one variant, the plunger rod 120 may be formed from the recycledresin compositions described herein. In embodiments which incorporate asealing edge (not shown) into the plunger rod 120, the sealing edge (notshown) may also be formed from the recycled resin compositions describedherein. In one or more embodiments, the stopper 125 may be formed fromelastomeric or other known materials, while the plunger rod is formedfrom the recycled resin compositions and is attached to the stopper 125.

In one or more embodiments, the needle hub 130 may be formed from therecycled resin compositions described herein, while the needle cannula140 is made from known materials in the art. In one or more alternativeconfigurations, the needle shield 150 may also be formed from therecycled resin compositions disclosed herein.

FIG. 2 illustrates a scalpel 200 that includes an elongate handle 210and blade holder 220 for attaching a blade (not shown) to the elongatehandle. The scalpel 200 also includes a blade shield 230 that isremovably attached to the elongate handle 210 and/or the blade holder220 to protect the blade (not shown). In one or more embodiments, theelongate handle 210, blade holder 220 and/or the blade shield 230 may beformed from the recycled resin compositions described herein.

In one or more embodiments, medical devices formed from the recycledresin compositions described herein do not change color after beingsterilized which may be measured in terms of yellowness index. Forexample, the medical devices may be sterilized, as described above, andundergo no change in color or appearance.

The medical devices may be formed using various methods known in theart. For example, such methods include injection molding, blow molding,extrusion and/or roto or rotational molding. Other methods known in theart may also be utilized to form the medical devices or components.

The medical devices formed from the recycled resin composition describedmay include a plunger rod that exhibits functional performanceacceptable to users and/or clinicians.

In one or more embodiments, a plunger rod formed from the recycled resincompositions described above exhibit the same functional performance asplunger rods formed from non-recycled resin compositions or compositionsthat do not include any recycled content.

A third aspect of the present invention pertains to a method for formingmedical devices and components. In one or more embodiments, the methodincludes providing a melt blend composition of the recycled resincompositions described herein. The method includes stabilizing the meltblend composition and solidifying the composition in a pre-selectedshape, which may include a plunger rod, a syringe barrel, a catheter, ablood collection device, a surgical bland handle, a needle shield and aneedle hub. In one or more embodiments, stabilizing the melt blendcomposition includes stabilizing the melt blend composition to withstandexposure to gamma rays, electron beams, X-ray radiation and ethyleneoxide gas without compromising functional performance and/or aestheticappeal of the finished product.

According to one embodiment, the step of providing a melt blendcomposition comprises feeding a recycled resin component and one or moreof an antioxidant component, a slip additive component, an anti-staticcomponent, an impact modifier component, a colorant component, an acidscavenger component, a melt blend component, a clarifier component, aX-ray fluorescence agent component, a radio opaque filler component, asurface modifier component, a processing aid component and a reinforcingagent component into a melt compounding extruder. The step ofsolidifying the composition comprises one of injection molding thecomposition, extruding the composition and rotational molding thecomposition.

The recycled resin compositions, medical devices and components madefrom such compositions and the methods of making such medical devicesand components provide a unique supply chain system which reduces theimpact on landfills.

The present invention will be further understood by reference to thefollowing non-limiting examples; however, the scope of the claims is notto be limited thereby.

EXAMPLES

The Inventive Formulations 1-6 were prepared by mechanically mixingrecycled polypropylene resins with virgin polypropylene resins, whereinthe virgin polypropylene resins further comprised of antioxidants, acidscavengers and melt-stabilizer.

Inventive Formulation 1 included 60% by weight of recycled polypropylenecomponent A and 40% by weight of a virgin polypropylene component A.Virgin polypropylene component A included up to 0.8% by weight of ananti-oxidant component and a melt-stabilizer component and up to 0.3% byweight of an acid scavenger component.

Inventive Formulation 2 included 70% by weight of a recycledpolypropylene component B and 30% by weight of virgin polypropylenecomponent A, as described above.

Inventive Formulation 3 included 50% by weight of a recycledpolypropylene component C and 50% by weight of a virgin polypropylenecomponent A. as described above

Inventive Formulation 4 included 60% by weight of recycled polypropylenecomponent A and 40% by weight of a virgin polypropylene component B.Virgin polypropylene component B included up to 0.3% by weight of ananti-oxidant component and up to 0.2% by weight of an acid scavengercomponent.

Inventive Formulation 5 included 50% by weight of recycled polypropylenecomponent B and 50% of virgin polypropylene component B, as describedabove.

Inventive Formulation 6 included 60% by weight of a recycledpolypropylene component D and 40% by weight of virgin polypropylenecomponent A, as described above.

The physical properties of each of Inventive Formulations 1-6 wereanalyzed. Specifically, the flexural modulus, tensile strength @ yield,tensile strength @ break, tensile elongation @ yield, tensile elongation@ break, tensile modulus, Izod impact strength and heat deflectiontemperature of Inventive Formulations 1-6 are evaluated and providedbelow in Table 1. For comparison, typical ranges for the physicalproperties of virgin polypropylene components are provided in Table 2.

The flexural modulus was measured according to ASTM D790-03. The testswere carried out on five specimens of each of the Inventive Formulations1-6. The tests were carried out using a 0.05 in/min crosshead speed anda 2 inch support span length on an instrument provided by Instru-MetCorp., of Rahway, N.J., U.S.A. The specimens were formed using aninjection molding process and conditioned at 23° C. and 50% relativehumidity (RH) for 40 hours before the testing was performed. The averageflexural modulus measurement of each of the five samples for InventiveFormulations is provided in Table 1.

The tensile properties of Inventive Formulations 1-6 were evaluatedaccording to ASTM D638-03. The tests were carried out on five specimensof each of the Inventive Formulations 1-6. The tests were carried outusing a cross-head speed of 2.0 in/min on an instrument provided byInstru-Met Corp., of Rahway, N.J., U.S.A.

The type I tensile bar specimens were formed using an injection moldingprocess and conditioned at 23° C. and 50% RH for 40 hours before thetesting was performed. The average tensile strength @ yield, tensilestrength @ break, tensile elongation @ yield, tensile elongation @ breakand tensile modulus measurements of each of the five samples forInventive Formulations is provided in Table 1.

The Izod impact strength of Inventive Formulations 1-6 were evaluatedaccording to ASTM D256-02. The tests were carried out on ten specimensof each of the Inventive Formulations 1-6. The average Izod impactstrength measurements for Inventive Formulations 1-6 are provided inTable 1.

The heat deflection temperature of Inventive Formulations 1-6 wereevaluated according to ASTM D648-06 using an HDT/Vicat instrumentavailable from Tinius Olsen, Inc. of Horsham, Pa., U.S.A. under a loadof 66 psi. The average heat deflection temperature for InventiveFormulations 1-6 are provided in Table 1.

TABLE 1 Physical Properties of Inventive Formulations 1-6. InventiveFormulation 1 2 3 4 5 6 Flexural Modulus (psi) Average 174345 148373207247 187735 159857 157830 Standard 2153 1288 4749 4200 2629 1385Deviation Tensile Strength @ Yield (psi) Average 4694 4372 4959 49194737 4408 Standard 77 74 100 42 41 56 Deviation Tensile Strength @ Break(psi) Average 2228 2665 4044 4058 2740 2798 Standard 304 81 779 162 8184 Deviation Tensile Elongation @ Yield (%) Average 9.67 11.1 8.37 7.879.27 8.41 Standard 0.750 0.558 0.255 0.515 0.436 0.939 Deviation TensileElongation @ Break (psi) Average 116 254 24.8 23.2 165 241 Standard 141121 15.3 3.50 40.5 62.3 Deviation Tensile Modulus (psi) Average 238539205376 264521 251694 234553 234458 Standard 7031 11233 6799 9940 115612841 Deviation Izod Impact Strength (ft-lbs/in) Average 0.46 0.51 0.530.53 0.44 0.51 Heat Deflection Temperature (° C.) Average 84.6 77.8109.3 92.2 96.1 104.9

TABLE 2 Typical Physical properties of Virgin polyolefin resins.Physical Properties Flexural Modulus 145037.7 psi (1000 MPa)-290075.4psi (2000 MPa) Tensile strength @yield 3625.9 psi (25 MPa)-6526.7 psi(45 MPa) Tensile elongation @yield 6%-15% Tensile Modulus 145037.7 psi(1000 MPa)-261067.9 psi (1800 MPa) Notched Izod Impact 0.3 ft-lb/in-1.0ft-lb/in Strength Heat Deflection 70° C.-110° C. Temperature

The physical properties of the Inventive Formulations 1-6 are comparableto the physical properties of virgin polyolefin resins, shown in Table2. Accordingly, the recycled resin compositions described herein achievethe goals of utilizing recycled resins that are biocompatible and usefulfor medical device applications, without compromising the physicalproperties of the resulting devices.

Inventive Formulations 1-6 were also analyzed for biocompatibility.Specifically, each of Inventive Formulations 1-6 was analyzed inaccordance with ANSI/AAMI/ISO 10-993-5 and the United StatesPharmacopeia Biological Tests and Assays, Biological Reactivity Tests,in Vitro <87>. The United States Pharmacopeia Biological ReactivityTests, in Vitro <87> are designed to determine the biological reactivityof mammalian cell cultures following contact with elastomeric plasticsand other polymeric materials with direct or indirect patient contact orof specific extracts prepared from the materials under test. The elutiontest described in United States Pharmacopeia Biological ReactivityTests, in Vitro <87> was carried out on Inventive Formulations 1-6.

Each of Inventive Formulations 1-6 passed or met the standard for thecytotoxicity tests with a United States Pharmacopeia score of zero,thereby meeting the criteria for preclinical toxicological safetyevaluation established by United States Pharmacopeia and ISO 10-993-5.All of the biocompatibility tests were conducted in accordance with GoodLaboratory Practice or GLP principles following procedures known in theart.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A method of forming a medical device comprising:providing a melt blend composition including a 50% to 99% recycled resincomponent, the melt blend composition having a cytotoxicity score ofzero; stabilizing the composition to withstand exposure to gamma rays,electron beams, X-ray radiations, ethylene oxide gas, autoclave, plasmasterilization; and solidifying the composition in a pre-selected shape.2. The method of claim 1, wherein providing a melt blend compositioncomprises feeding a recycled resin component and one or more of anantioxidant component, slip additive component, anti-static component,impact modifier component, colorant component, acid scavenger component,nucleating agents, clarifiers, x-ray fluorescence agent component, radioopaque filler component, surface modifier component, processing aidcomponent and reinforcing agent component into a melt compoundingextruder.
 3. The method of claim 1, wherein solidifying the compositioncomprises one of injection molding the composition, extruding thecomposition, blow molding the composition and rotational molding thecomposition.
 4. The method of claim 1, wherein the pre-selected shapecomprises one of a plunger rod, a syringe barrel, a catheter, a bloodcollection device, a surgical blade handle, a needle shield, safetyshield, catheter wings, catheter flow control plugs and a needle hub,sharps containers, body fluid collection devices, tubing, adapters anddrainage tubes.
 5. The method of claim 1, further comprising stabilizingthe composition to withstand exposure to gamma rays in the range fromabout 5 kGys to about 75 kGys.
 6. The method of claim 1, wherein therecycled resin component is biocompatible.
 7. The method of claim 1,wherein the recycled resin component comprises from about 0.1% to about100% by weight recycled resin selected from one of post-industrialrecycled resin, post-consumer recycled resin and combinations thereof.8. The method of claim 1, wherein the melt blend composition furthercomprises one or more of a virgin resin component and/or a biobasedresin component.
 9. The method of claim 8, wherein the composition ofrecycled resin composition mechanically mixed with virgin polypropyleneresin comprises 60% by weight of recycled resin composition and 40% byweight of the virgin polypropylene resin.
 10. The method of claim 8,wherein the composition of recycled resin composition mechanically mixedwith virgin polypropylene resin comprises 70% by weight of recycledresin composition and 30% by weight of the virgin polypropylene resin.11. The method of claim 8, wherein the composition of recycled resincomposition mechanically mixed with virgin polypropylene resin comprises50% by weight of recycled resin composition and 50% by weight of thevirgin polypropylene resin.
 12. A composition for molding a medicaldevice comprising: a recycled resin sourced from a traceable source; andone or more of an antioxidant component, slip additive component,anti-static component, impact modifier component, colorant component,acid scavenger component, x-ray fluorescence agent component, radioopaque filler component, surface modifier component, processing aidcomponent, melt stabilizer component, clarifier component, nucleatingagents and reinforcing agent component, wherein the composition isbiocompatible and has a cytotoxicity score of zero.
 13. The compositionof claim 12, wherein the composition is capable of withstanding exposureto gamma rays in the range from about 5 kGys to about 75 kGys.
 14. Thecomposition of claim 12, wherein the composition is capable ofwithstanding exposure to electron beams in the range from about 30 kGysto about 100 kGys.
 15. The composition of claim 12, wherein thecomposition is capable of withstanding exposure to one of X-rayradiation, ethylene oxide gas, autoclaving and plasma sterilization. 16.The composition of claim 12, comprising a flexural modulus in the rangefrom about 70 kpsi to about 350 kpsi.
 17. The composition of claim 12,comprising a melt flow range in the range from about 3 dg/minute toabout 80 dg/minute.
 18. The composition of claim 12, comprising a heatdeflection temperature from about 60° C. to 260° C.
 19. The compositionof claim 12, comprising notched izod impact strength in the range fromabout 0.1 ft-lb/in to about 4.0 ft-lb/in.
 20. The composition of claim12, further comprising one or more of a virgin resin component and abiobased resin component.